Bates Sylvia M, Hill Valerie A, Anderson John B, Chapple Christopher R, Spence Rosemary, Ryan Claire, Talbot Martin D
Department of Genito-Urinary Medicine, Royal Hallamshire Hospital, Sheffield, UK.
BJU Int. 2007 Feb;99(2):355-9. doi: 10.1111/j.1464-410X.2007.06667.x.
To assess the validity of our observational experience that a short course of oral prednisolone therapy might be of value in the management of symptoms of chronic pelvic pain syndrome (CPPS) in men.
Twenty-one men with CPPS (inflammatory or non-inflammatory) for > or =6 months, and who had failed to improve with standard antibiotic therapy, were randomized to receive either a 1-month reducing course of oral prednisolone (nine) or an equivalent placebo regimen (12 men). The outcome measures used were the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale (HADS), General Health Questionnaire-30 (GHQ-30) and the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), which were completed at baseline and 3 months.
Outcomes were analysed for the 18 patients (six treated, 12 placebo) who completed the 3 months of follow-up. At both baseline and 3 months, respectively, there was no statistically significant difference between the groups in the NIH-CPSI total score (P = 0.48 and 0.62; Mann-Whitney U-test), or in the HADS (anxiety, P = 0.85 and 0.67; depression P = 0.96 and 0.74), and there was no significant improvement or deterioration over time. Although not statistically significant, there was a trend to improvement in the depression score for the active group (P = 0.13). However, the clinical significance is doubtful, as both baseline and follow-up depression scores were within the normal range. No patient had clinically negative changes in depression. A 3-month follow-up analysis was not possible for the McGill Pain Questionnaire or GHQ-30 as not all patients completed the questionnaire.
Whilst the study showed no clinical benefit of using corticosteroids in the management of CPPS, the few patients recruited limited the validity of firm conclusions from the data. There was a trend towards an improvement of depression levels amongst subjects. The study highlights the difficulties of recruitment and illustrates the complex psychological profiles of patients with CPPS.
评估我们的观察经验,即短期口服泼尼松龙治疗可能对男性慢性盆腔疼痛综合征(CPPS)症状的管理有价值。
21名患有CPPS(炎症性或非炎症性)且病程≥6个月、标准抗生素治疗无效的男性,被随机分为两组,一组接受为期1个月的口服泼尼松龙递减疗程治疗(9人),另一组接受等效安慰剂治疗(12人)。采用的结局指标包括麦吉尔疼痛问卷、医院焦虑抑郁量表(HADS)、一般健康问卷-30(GHQ-30)和美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI),这些指标在基线和3个月时完成评估。
对完成3个月随访的18名患者(6名治疗组,12名安慰剂组)的结局进行了分析。在基线和3个月时,两组在NIH-CPSI总分(P = 0.48和0.62;曼-惠特尼U检验)、HADS(焦虑,P = 0.85和0.67;抑郁,P = 0.96和0.74)方面均无统计学显著差异,且随时间无显著改善或恶化。虽然无统计学显著差异,但治疗组的抑郁评分有改善趋势(P = 0.13)。然而,由于基线和随访时的抑郁评分均在正常范围内,其临床意义存疑。没有患者出现临床上的抑郁负面变化。由于并非所有患者都完成了问卷,因此无法对麦吉尔疼痛问卷或GHQ-30进行3个月的随访分析。
虽然该研究表明使用皮质类固醇治疗CPPS无临床益处,但纳入的患者数量较少限制了从数据得出确凿结论的有效性。受试者的抑郁水平有改善趋势。该研究凸显了招募患者的困难,并说明了CPPS患者复杂的心理状况。